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Comparative Study
. 2018 Jun 25;56(7):e00614-18.
doi: 10.1128/JCM.00614-18. Print 2018 Jul.

Comparison of the QuantiFERON-TB Gold Plus and QuantiFERON-TB Gold In-Tube Interferon Gamma Release Assays in Patients at Risk for Tuberculosis and in Health Care Workers

Elitza S Theel  1 , Heather Hilgart  2 , Margaret Breen-Lyles  3 , Kevin McCoy  4   5 , Rhiannon Flury  5 , Laura E Breeher  6 , John Wilson  4   7 , Irene G Sia  4   7 , Jennifer A Whitaker  4   7 , Jeremy Clain  4   8 , Timothy R Aksamit  4   8 , Patricio Escalante  4   8
Affiliations
Comparative Study

Comparison of the QuantiFERON-TB Gold Plus and QuantiFERON-TB Gold In-Tube Interferon Gamma Release Assays in Patients at Risk for Tuberculosis and in Health Care Workers

Elitza S Theel et al. J Clin Microbiol. .

Abstract

The QuantiFERON-TB Gold Plus (QFT-Plus; Qiagen, Germantown, MD) interferon gamma release assay (IGRA) received FDA clearance in 2017 and will replace the prior version of the assay, the QFT-Gold In-Tube (QFT-GIT). Here, we compared performances of the QFT-Plus assay and the QFT-GIT version in a diverse patient population, including patients undergoing evaluation for or follow-up of latent tuberculosis infection (LTBI; n = 39) or active TB infection (n = 3), and in health care workers (HCWs; n = 119) at Mayo Clinic (Rochester, MN). Compared to the QFT-GIT, the QFT-Plus assay showed 91.2% (31/34) positive, 98.4% (124/126) negative, and 96.6% (156/161) overall qualitative agreement among the 161 enrolled subjects, with a Cohen's kappa value of 0.91 (excellent interrater agreement). Among the 28 patients diagnosed with LTBI at the time of enrollment, the QFT-GIT and QFT-Plus assays agreed in 24 (85.7%) patients; in all four discordant patients, the positivity of the QFT-GIT or QFT-Plus IGRA was associated with low-level interferon gamma (IFN-γ) reactivity, ranging from 0.36 IU/ml to 0.66 IU/ml. Additionally, we document a high degree of correlation between IFN-γ levels in the QFT-GIT TB antigen tube and each of the two QFT-Plus TB antigen tubes, as well as between the QFT-Plus TB1 and TB2 tubes (Pearson's correlation coefficients [R] > 0.95). Overall, we show comparable results between the QFT-GIT and QFT-Plus assays in our study population composed of subjects presenting with a diverse spectrum of TB infections. Our findings suggest that the necessary transition to the QFT-Plus assay will be associated with a minimal difference in assay performance characteristics.

Keywords: IGRA; LTBI; QuantiFERON-TB Gold In-Tube; QuantiFERON-TB Gold Plus.

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Figures

FIG 1
FIG 1
Correlation of QFT-GIT and QFT-Plus quantitative IFN-γ values. Graphs show correlations between quantitative results for the QFT-GIT TB antigen tube and QFT-Plus TB1 tube (A), the QFT-GIT TB antigen tube and QFT-Plus TB2 tube (B), and the QFT-Plus TB1 tube and QFT-Plus TB2 tube (C). R, Pearson's correlation coefficient.
See this image and copyright information in PMC

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